Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Tuesday, May 30, 2006

From the New York Times, a striking example of a patients and physicians caught in the cross-fire between managed care and a hospital, and of the sort of tactics used by large US managed care organizations these days.

One party to the conflict is Jamaica Hospital Medical Center (in New York City, not the Caribbean), described as serving "a largely poor population with many immigrants and a large number of uninsured patients." The other is Oxford Health Plans, now a subsidiary of UnitedHealthGroup. We have posted, most recently here, (and see links to earlier posts) about the leadership of UnitedHealth, whose CEO, Dr William McGuire, has amassed over $1.6 billion worth of stock options, the timing of the granting of which is currently being investigated by the SEC and a federal grand jury.

Here is the story:

In interviews and court papers, Michael D. Brown, a lawyer for Jamaica, as well as Mr. Rosen and other MediSys officials, gave the following account of the dispute; UnitedHealth and Oxford declined to respond because of the litigation.

Jamaica officials noted that the Oxford moves they object to happened after the July 2004 takeover by UnitedHealth, one of the nation's largest and most profitable health insurers.

In 2004, MediSys and Oxford negotiated new contracts to set the rates the insurer would pay to two MediSys hospitals, Flushing Hospital Medical Center and Jamaica. Oxford drafted the contracts, and MediSys signed them and returned them to Oxford. In each case, based on custom and verbal understanding with Oxford, it was expected that the insurer would sign right away, and that the contract would go into effect the following month.

But after a few months, MediSys realized that Oxford was still paying the old, lower rates, and it complained to the insurer. At that point, Oxford raised a new and unexpected subject: the anesthesiologists at Flushing Hospital.

Those doctors are not Flushing employees, but an independent partnership with an exclusive contract to provide anesthesia services at the hospital — a typical arrangement. The anesthesiology group does not have an agreement with Oxford to be part of its network of doctors. When Oxford members have surgery at Flushing, the anesthesiologists bill the insurance company for their full fees, not the lower rates Oxford would negotiate with in-network doctors.

In late 2004 and early 2005, when MediSys protested that Oxford was not abiding by its new contracts, Oxford responded by asking the hospitals to pressure the Flushing anesthesiologists to join Oxford's network. MediSys rebuffed that request, saying it was up to the anesthesia group to make its own insurance arrangements.

Oxford signed the contract with Jamaica on April 25, 2005 — almost four months after hospital officials thought the contract had gone into effect. But even then, Oxford did not start paying Jamaica the new rates.

On March 27, Mr. Brown received Oxford's first written response to Jamaica's complaints — an e-mail message from a senior vice president at Oxford. The message, included in Jamaica's court papers, was an offer to pay the new rates, both in the future and retroactively, on the condition that the Flushing anesthesia group make a deal with Oxford. MediSys continued to insist that it could not compel those doctors to join Oxford's network.

In early April, doctors and patients received letters from Oxford informing them that as of May 2, Jamaica would no longer be an Oxford provider. Doctors who had admitting privileges at other hospitals were told that they would have to take their patients elsewhere. Doctors who had privileges only at Jamaica were told that they would no longer be paid to treat Oxford members, and their patients were told to find new doctors.

Dr. Alan R. Roth, a family practitioner with many patients at Jamaica Hospital, said he had hundreds of Oxford patients who received such letters.

'A lot of these are low-income, elderly people who have heart disease and diabetes and arthritis, people who see a lot of different specialists, and they were panicked,' he said. 'And all of a sudden, they're told they can't go to all those docs at Jamaica they're used to seeing, who coordinate care with me.'

Jamaica complained to the state, and in April, it sued Oxford in State Supreme Court in Queens. Oxford agreed to keep doing business with Jamaica through Aug. 1.

It appears that UnitedHealth Group, through its Oxford subsidiary, was willing to hold hostage its relationship with Jamaica Hospital, and thus risk that many patients would have to find new doctors and many doctors would have to rearrange their practices, in order to pressure a single anesthesia group into signing a contract with Oxford.

These are apparently the sorts of tactics used by UnitedHealth that inspired UnitedHealth board member (and Columbia University Dean of Nursing) Mary Mundinger to proclaim "We're so luck to have Bill [McGuire]. He's brilliant." However, these tactics seem to conflict with the stated mission of UnitedHealth Group which includes as a goal "to improve access to health and well-being services" and to "simplify the health care experience."

Sunday, May 28, 2006

More on how pharmaceutical companies may be skewing the drug sales playing field through influence on the medical nonprofit specialty societies that are held in high regard by patients and clinicians alike:

The National Alliance on Mental Illness, an outspoken patient advocate, lobbies for treatment programs that also benefit its drug-company donors.

The National Gaucher Foundation, a supporter of people suffering from a horrific rare disease, gets nearly all its revenue from one drugmaker, Genzyme Corp.

Although patients seldom know it, many patient groups and drug companies maintain close, multimillion-dollar relationships while disclosing limited or no details about the ties.

At a time when people are making more of their own health-care decisions, such coziness raises questions about the impartiality of groups that patients trust for unbiased information. It also poses a challenge for groups trying to hold patients' trust and still raise money to serve them. An Inquirer examination of six groups, each a leading advocate for patients in a disease area, found that the groups rarely disclose such ties when commenting or lobbying about donors' drugs. They also tend to be slower to publicize treatment problems than breakthroughs. And few openly questioned drug prices.

I agree with this assessment. While these groups perform an important function, especially in education and advice to patients, the covert involvement of industry in this sector seems inappropriate, even from the free-market viewpoint.

These organizations are not commercial and should not be used in any way as an avenue for increased drug advertising or "branding" with patients. The lack of disclosure mentioned in the Inquirer article is at the heart of the matter. Apologists who offer opinions that the money does not influence insiders at these organizations are deluding themselves.

Worse, the money seems to come not from R&D or the charitable arms of these drug companies but from marketing:

The donations are sometimes portrayed by the companies and nonprofits as "giving back" to patients. But the funding usually comes from the companies' marketing or sales divisions, not charity offices, company and nonprofit officials said. Grants often rise with promotional spending as a drug hits the market and fall when sales ebb.

Donations from Merck and Pfizer Inc. to the Arthritis Foundation more than doubled, to at least $1.65 million combined, in 2000 as they launched Vioxx and Celebrex. The donations fell below $375,000 by 2004, when safety fears had flattened sales, foundation reports show.

Merck explicitly wove the foundation into sales strategies. A 2001 internal memo, disclosed in product-liability trials, shows that Merck sought to use the foundation's pain-management program to "demonstrate additional benefits" of its products.

Practices like this at pharmas really teeter on the precipice of unethicality on the part of marketing. Merck, for example, had corporate values that asked employees to ask themselves "how would it appear in print?" as a step for evaluating the ethics of some planned action.

In this case, the Philadelphia Inquirer has just answered that question.

Gretchen Morgenson, the inimitable Cassandra of the NY Times today publishes a superb piece on Enron and its aftermath. Read it while it's still available on a no-pay basis. She avers that the Enron verdicts are not the beginning of the end of the current, laudable, phase of house-cleaning, but just the end of the beginning.

We may only hope that her analysis proves prescient. And we may only hope that we start seeing more of these prosecutorial energies poured into malfeasance over here in the healthcare briar patch. Dr. Poses and I have spoken often about the peculiar anechoic effect that seems still to hold sway in medicine. It must end.

That's why I blog this article by the intrepid Times reporter. Her final words are especially apt: "Unfortunately, questionable corporate practices continue apace." And: "As the Enron jury eloquently told us last week, silence in the face of these offenses gives consent."

The Times reported, "nearly 500 doctors have been dropped from a health plan run by Regence BlueShield, one of the state's largest health insurers, which has sent letters to some 8,000 patients contending that the doctors' 'quality and efficiency' didn't measure up." However, it is not clear how Regence rated the physicians. Dr Peter Dunbar, President of the Washington State Medical Association, noted "Regence has a black box," he said. "The individual physician has no idea what's being measured."

The Times reported, "Dr. Joe Gifford, chief medical officer for Regence, said the rating system looks at doctors' 'quality measures,' such as prescribing the appropriate medications for congestive heart failure or asthma." However, apparently the data it uses "is taken entirely from billing data." As we have noted earlier, such data does not include clinical information that would allow adequate control for disease severity and other patient characteristics that may affect both process and outcome measures. Also, it is frequently unreliable.

The Medical Society is demanding that Regence suspend the system and apologize to physicians. Dunbar noted that telling patients that the plan dropping doctors from the plan because of poor "quality and efficiency" is "a pretty egregious thing to say about somebody in print. This is a very heavy-handed, crude message." But what did he expect from a large health care bureaucracy?

The latest issue of the American Medical News took on pay for performance (p4P), including the views of some skeptics. We had posted about some of the potential problems with the pay for performance concept here. Note that P4P in health care these days pretty much is restricted to payers (managed care, government agencies, and/or employers) rating physicians on their "performance," and then giving them financial incentives accordingly.

Let me suumarize some of the concerns about pay for performance, quote some of the skeptics interviewed by the American Medical News, then quote responses from the P4P advocates, and add my comments.

P4P May Use Outcome Measures Without Adjusting Adqeuately for Patients' Characteristics, Leading to Perverse Incentives

It's going to be a lot easier to treat a little old lady from Beverly Hills. Some communities are more compliant and more health-literate and have more resources to influence outcomes than others. I may treat you exactly correctly and give you the right pills, but if you have to choose between buying pills and giving your baby milk, that drug may lose out and my performance may be judged as poor because of it.

Dr Roy M. Poses (that's me) said:

Outcomes are determined not just by what the physician does but by how sick the patient is, what his or her other characteristics are, and to some extent, by chance. If you don't control for patient characteristics, you can have a perverse system.

It's recognized by everyone that these are not measures that are under the control of an individual clinician, but there are important things a primary-care provider can to do to encourage patients to adopt the right behaviors.

Then what sense does it make to use the measures to assess physicians? Outcomes that are beyond an "individual clinician's" control do not reflect that clinician's performance.

Furthermore, Dr Greg Pawlson, executive vice president of the National Committee for Quality Assurance, said,

Not everybody's patients can be sicker.

No, but a system that gives poorer grades to physicians whose patients actually are sicker would be perverse.

Process-Based Measures Should Reflect Processes Actually Under the Control of Physicians

Dr Chuck Kilo said,

Do I get dinged if a diabetic chooses not to have their A1c tested, or is my recommendation sufficient to get credit? If so, then that leaves a lot of room for gaming the system.

Measures Based on Administrative Data are Suspect Because the Quality of the Data May be Poor

Dr Kilo also said,

Health plans have been measuring practices and sending data back for a long time, and most doctors would throw them in the circular file. Somewhere between 10% or 50% of the patients they have listed as mine are not mine. It doesn't take a whole lot of erroneous data built into it for doctors to write off the whole thing.

Measures Meant to Control Costs Will Not Measure Quality

I said,

If the measurement systems or incentives are really designed to save costs for health plans, they may push physicians not to do that which would be the best for the patient in terms of clinical care and clinical outcomes. The devil is in the details.

Summary

It's nice to see some balanced coverage of this issue, given all the hype it's getting from managed care, government agencies, and payers.

Remember that there are problems with P4P as it's currently formulated that were not addressed by this article. In particular, most pay for performance measures so far are about primary care, or primary and secondary prevention. Few are about specialty care, diagnosis, or management of acute illnesses. Furthermore, most measures are targeted at single diseases, and developed from studies of patients with only one disease. Few take into account management of patients with multiple diseases (who are not rare), or management of patients with ill-defined complaints. Measures focused on only a fraction of medical care can lead to another kind of perverse effect. Pushing doctors only to improve their performance in very limited areas may reduce their time and resources to even maintain performance in other areas. Since performance in those other areas is not measured, no one may notice it declining.

Thursday, May 25, 2006

The Lancet this week contains a commentary from the WHO [Sim I, Chan AW, Gulmezoglu AM, Evans T, Pang T. Clinical trial registration: transparency is the watchword. Lancet 2006; 367: 1631-33.] calling for the creation of an international clinical trials registry. It is worth quoting from its introduction:

Recent scandals in the UK and elsewhere have diminished public trust in the clinical research industry. [References were to trials of TGN 1412 ; Vioxx; and Trovan in Africa.]Transparency is the best antidote to such free-floating distrust. Clinical trial registration will allow the necessary tracking of trials to ensure full and unbiased reporting of the results for public benefit.Individuals voluntarily participate in trials expecting that the results will be used to improve medical knowledge in general, and not only to serve proprietary or commercial interests. These ethical oblibations to the public good are in addition to the obligations to protect individual research participants during a trial (e.g., informed consent), and they extend to all trials regardless of study design or trial population.

Their emphasis on trial subjects' expectations that they are contributing to science, not just to a commercial project, is a welcome reminder. The authors underline this point later, asserting that their registry proposals

are consistent with the Declaration of Helsinki requirement that 'the design of all studies should be publicly available', as well as with the recognition by the Declaration of Helsinki and the Nuremburg Code that the rights of trial participants hold primacy over commercial and career interests.

The proposed WHO registry will include early trials (called Phase I and II in the US) as well larger, late-phase trials is important. Their argument was that early-phase trials "are often terminated for economic reasons." But that registration of them will "ensure that information about the risks of new interventions will be publicly available."

The WHO authors found that "arguments for delayed disclosure were neither convincing nor compelling. First, there is a large variation in disclosure practices - some companies disclose all outcomes, some none - raising the question of what disclosure is truly threatening. Second, information that is claimed to be sensitive is often available for a fee through intelligence services readily found on the internet or through trial participants and consumer websites. Finally, there is no convincing evidence that disclosure threatens competition and hence innovation."

This sort of clarity about the integrity of clinical research is welcome. Hopefully, it will get some attention.

Monday, May 22, 2006

Health Affairs recently interviewed Dr David Baltimore, the current President of the California Institute of Technology, and winner of a Nobel Prize. Its abstract stated, "as a man with equal interests in science and science policy, David Baltimore has been at the forefront of many of the important debates that have shaped science since the 1970s." [Culliton BJ. Science for life: a conversation with Nobel Laureate David Baltimore. Health Aff 2006; 25: w235-240.]

The interviewer pretty much let Dr Baltimore sing the praises of biotechnology. The article included his justification for the extremely high prices of biotechnology drugs. He acknowledged prices were high, but felt the prices were justified by the benefits, and to some extent the small size of the market for the drugs.

Well, the people who do benefit, benefit enormously. I would only support a system that enabled those people to get them. Now, the cost of their getting it could be very high. But we’re willing to pay enormous sums of money for people to get drugs that are worthwhile.... But they’ve been able to charge hundreds of thousands of dollars per patient per year for the drug because people believe that it’s important for it to be available. And it’s not because the drug is so expensive to make. It’s because there are so few patients who need it that to have a supply of it and therefore to make it valuable to the company to produce it, they’ve got to charge a lot for it.

Furthermore, Dr Baltimore argued that the US is rich enough to afford high-priced biotechnology drugs.

We’re in a highly developed country where it’s a matter of, Do you spend the money to keep a few people alive, or do you spend the money on something crazy like the war in Iraq? In my opinion, it is much more important to keep those few people alive.

Also

That industry has provided expensive treatments for life-threatening diseases. It’s clearly met previously unmet medical needs. And the overall financial burden on the health care system, as I understand it, is not enormous because drugs are still 10–15 percent of medical costs. So for all the development of biotechnology, it has not overwhelmed the health care industry.

Finally, he argued for the economic benefits of the biotechnology industry.

And the amount of revenue that comes to the state of California is clearly in the billions of dollars. You know, a company like Amgen—one of the early biotech companies—probably employs 15,000 researchers and other workers. So, sure, these are big companies. Amgen is the cornerstone of the wealth of Thousand Oaks.

The interview did include a brief aside about conflict of interest, an issue that Dr Baltimore did not find very problematic.

This can be a sticky issue, but I think most universities have handled it well. The major conflicts relate not to basic research but to clinical research.
We have not instituted new policies at Caltech, but we do monitor the situation closely.

All in all, it amounted almost to a hymn of praise for biotechnology, unmarred by any doubts about its usefulness or value to society, or any doubts that society should pay every dollar charged by biotechnology companies. It was quite a striking testimonial, coming as it did from a Nobel Laureate.

What the article left out was that it was also coming from someone with very strong financial ties to the biotechnology industry. In fact, Dr Baltimore sits on the board of directors of three biotechnology companies: Amgen, MedImmune, and Cellerant Therapeutics. Note that Dr Baltimore above praised the economic contribution of Amgen to California without acknowledging his legal responsibility to maximize the profits of that self-same corporation.

If Health Affairs wants to let a member of the board of directors of Amgen sing the praises of biotechnology, that is fine, but the journal should thus identify that person. Readers ought to know about strong financial interests, and in this case, fiduciary interests, that may have bearing on the content of what they publish.

The Boston Globe just published several articles about the the Boston-area Caritas Christi Health Care System, and especially the conduct of its CEO, Dr Robert M Haddad.

The background, per the Globe, is that Caritas has had a tumultuous few years. Cardinal Sean P O'Malley "fired longtime leader Dr Michael Collins for undisclosed reasons...." in 2004. He then "replaced him with interim president Emmet C Murphy, a healthcare consultant whom O'Malley had hired to evaluate the system and who was advocating for changes. But soon after, Murphy disclosed his departure after Globe reporters asked him to explain several discrepancies in his official biography." But, "since taking over as chief executive two years ago, Dr Robert M Haddad had begun to turn around the financially precarious Caritas Christi Health Care System."

However, this action was insufficient, according to Helen G Drinan, senior vice president for human resources. She had advised the Cardinal that "Caritas had 'always fired other employees who have engaged in similar behavior. She also advised him that both she and Jean Musiker, an outside lawyer who was brought in to conduct an independent inquiry, concluded that Hadda violated federal workplace law, as well as the written sexual harassment prohibitions at Caritas Christi...." Caritas' policy defines sexual harassment as including "'unnecessary touching of an individual, e.g., patting, pinching, hugging, repeated brushing against another person's body.' The policy is signed by Haddad."

Further, Drinan wrote, "I cannot stand aside or participate in an effort to protect the institution and its powerful leader [Haddad] as priority over compassion for those injured by shameful and inexcusable conduct." She warned, "I know what will befall this organization when the public learns that the Church in Boston has once again put the powerful predator ahead of the powerless victim."

Today, the Globe added that "the [Caritas] board was told Thursday that there were more than the four women involved." Further, "one of the board members said yesterday that he felt misled after he learned in yesterday's globe that Caritas Christi had fired other men for similar behavior." A list provided by Drinan "shows that five man were dismissed between 2003 and 2005 for various incidents involving kissing or hugging. One case, in 2004, involved a senior physician who kissed and hugged a senior clinician. There was just one victim in each of the five cases."

This is just another example that the leaders of large health care organizations are different from you and me. They need not follow the rules imposed on less influential employees (even if they, as in this case, signed the rules themselves.)

This case is unusual in that the rules involved were about sex, not money. The definition of sexual harassment used in this institution may be controversial. However, the issue is the Caritas rules were allegedly enforced differently when their object was not a staff member, or even a "senior physician," but the CEO.

But until we finally discredit the culture of the "imperial," make that despotic CEO, such abuses will continue.

ADDENDUM (May 26, 2006) - After the Boston Globe articles mentioned above got wide attention, the Caritas Christi Health Care System Board reconsidered, and forced Haddad to resign, again according to the Globe.

Almost a year ago we discussed a dispute that had broken out within the American Society of Hypertension (ASH) about the role of industry in and conflicts of interesting affecting the society's work.

The New York Times has followed-up with another story, this one highlighting the society's role in a new and more expansive definition of hypertension. This definition included some people with "pre-hypertension," previously defined as a blood pressure between 120/80 and 139/89, within a newly defined "state 1 hypertension" group. This expanded definition appeared in an article whose lead author was the current President of ASH (Giles GD, Berk BC, Black HR, Cohn JN, Kostis JB, Izzo JL Jr, Weber MA. Expanding the definition and classification of hypertension. J Clin Hypertens 2005; 7: 505-512.) The Times noted that "of the seven doctors who wrote the proposed new definition, six have said they served as consultants and speakers for pharmaceutical companies that make blood pressure medications. The seventh is a consultant and stockholder in a company that markets a diagnostic method to measure damage to blood vessels."

The Times also noted "the work of the group that developed it was financed by $75,000 in unrestricted drug industry grants from Merck, Novartis and Sankyo...." Furthermore, a society staffer "confirmed that the dinners [to discuss the new guidelines] were financed by $700,000 in grants, also unrestricted, from the same companies."

Internal critics within the society criticized the process. "This is about the monetarization of medicine," said former society President Dr Michael H Alderman, who had withdrawn from the group which proposed the new hypertension definitions. Furthemore, he noted, "all this has got the ring of seeming to be of great benefit to the pharmaceutical industry without clear evidence that it's going to be the same benefit to the public." Dr Curt D Furberg, from Wake Forest University, also withdrew from the group. He charged that "its work was not evidence-based, ... [and] 'the industry wants to sell drugs and to as many people as possible.'" Jane E Sealey, who had been President-Elect of the society, said, "the truth of the matter is that we have many members who are leaders in our society who are making well into the six figures from their pharmaceutical-company-supported activities." Dr Sealey immediately resigned her presidency at the society's annual meeting, according to theHeart.org.

ASH President Giles countered that "the organization had always maintained a firewall between its activities and industry funding. 'We don't take money that has strings attached to it.'" One of the authors of the new hypertension definition, Dr Joseph L Izzo of the University of Buffalo, said "there are those who accuse us of being nothing more than shills of industry: a lot of us take pretty great offense at that."

This seems to be another example of how disease definitions get expanded, often with some degree of participation by pharmaceutical companies who have interests in increasing the market for their products. Note also that the sorts of possible conflicts of interest described may have largely unconscious effects on those affected, as we have discussed. So the indignation of people who are not conscious "shills of industry" is real, but perhaps misplaced.

Furthermore, this is another case that suggests physicians and patients need to be increasingly skeptical about the apparently authoritative guidelines that now rain down on us.

Finally, the Times also reported that Dr Steven E Nissen, new president of the American College of Cardiology, "suggested that the medical profession had become addicted to industry money just as the nation was addicted to foreign oil." Maybe it's time to kick the habit.

Sunday, May 21, 2006

We had posted a while back and again here about the story of Dr Aubrey Blumsohn's dispute with Proctor and Gamble (P&G) and Sheffield University in the UK. In summary, Blumsohn and Professor Richard Eastell had done clinical research on the risedronate (Actonel), sponsored by P&G, the drug's manufacturer. P&G refused Blumsohn access to the original data from the study he was ostensibly running, and hired a ghost-writer to write abstracts in his name. Blumsohn protested to Eastell, who advised him not to make waves because P&G "is a good source of income" for the university. When protests to other university officials produced no results, Blumsohn told the story to the press, whereupon the university suspended him.

Dr Blumsohn will be in northern North America (Canada and the USA) next month, speaking at a number of venues. His schedule is below:

University of Toronto, Toronto, Canada - 19 June 2006
Time: 16:00-18:00, reception to follow, 18:00 - 20:00
Location: Bennet Lecture Hall, University of Toronto. Reception to follow in Rowell Room (Flavelle House )
Title: Where Are My Data? - Learning from Crises in Pharmaceutical Research: A New Story About the Pharmaceutical Benefactor, the University, the Ghost, a Lone Academic and the Bill of Rights
Contact Details: Ms Valerie Joseph (416)-340-4800 x 6507
Sponsored by: Doctors for Research Integrity and The Canadian Association of University Teachers, Trudo Lemmons, Faculty of Law; Nancy Olivieri, Faculty of Medicine (hosts)

Friday, May 19, 2006

Another large health care company has come under investigation over the timing of the stock-options given to its CEO. According to the Associated Press (via the Washington Post), "Pharmacy benefit manager Caremark Rx Inc said Thursday that it has received a federal grand jury subpoena for records about its stock options, a day after UnitedHealth Group Inc. was subpoenaed on the same subject. Caremark also received what it called an 'informal inquire' from the Securities and Exchange Commission (SEC), requesting information about the company's stock options and its relocation program." TheStreet.com further reported the inquiries came "three weeks after TheStreet.com highlighed the particularly well-timed stock option grants that Caremark gave CEO Mac Crawford and other company leaders last year. Caremark gratned those options at $37.92 a share, the lowest closing price of the year. Last week, the Wall Street Journal went on to show that Caremark had displayed some uncanny timing before. Notably, the Journal stated, Caremark issued stock options priced at $3.88 a share - 'which turned out to be tied for the low point of the year' - back in 2000."

Regarding the relocation issue, AP reported, "the Wall Street Journal last week reported that Caremark's chairman, president and chief executive, Mac Crawford, took part in the company's relocation program when it moved its headquarters from Birmingham, Ala., to Nashville in 2003." Furthermore, "Crawford was given a $2.9 million 'equity advance,' but has yet to sell his house in Alabama. A Caremark spokesman told the paper that Crawford's ill wife still lives there and that the home will be sold when renovations on the Crawford's Nashville home is [sic] complete."

Another day, another large health care organization under investigation for questionable practices. Yet patients, physicians, and other health care professionals have to deal with these large organizations every day. And we still wonder why health care is increasingly expensive and decreasingly accessible, while quality stagnates and physicians and nurses are ever more demoralized?

Now Reuters has reported that Sanofi-Aventis is in talks with the US Food and Drug Administration (FDA) about strengthening the warning label on the drug. A report from PharmaLive said that US Senator Charles Grassley (R-Iowa), chair of the Senate Finance Committee, is pressing the FDA for more information on how it handled the approval of Ketek. The letter said,

the Committee continues to investigate the extremely troubling allegations related to , among other things, the approval and post-market [sic] surveillance of telithromycin (Ketek) by the Food and Drug Administartion. One of the most troubling allegations is that the FDA approved Ketek with full knowledge that some of the clinical safety data supporting its approval was beset by systemic data integrity problems. While the FDA takes its time negotiating with Sanofi-Aventis to decide what drug risk information the public should know, it is completely mystifying why a fraudulant clinical trial is reference in safety information on the FDA's web-site.

The Disastrous Trial of TGN 1412 Done by Parexel for TeGenero

We have previously posted, most recently here and here, about the disastrous trial, implemented by Parexel International , of a new monoclonal antibody designated TGN 1412, manufactured by TeGenero AG. All six healthy volunteers who got the antibody soon became critically ill. We had previously noted allegations that there was reason to think prior to this trial that TGN 1412 would pose risks to human subjects.

The BBC interviewed several experts who also felt that TGN 1412 should have been regarded as a risky drug from the outset. For example, it quoted Dr David Glover, "it may be that it [the adverse effect] was unpredicted by the tests that were done. I believe from the basic science it was predictable." Professor David Winter, of the Laboratory of Molecular Biology in Cambridge said that "those testing TGN 1412 may have been lulled into a false sense of security by the fact that it did not seem to harm monkeys - but it was wrong to make too many assumptions based on animal experiments." In response, TeGenero "said it was an 'oversimplification' to suggest that the side effects could have been predicted in advance."

Multiple Clinical Trials Done by SFBC International

We have posted before about the troubles of contract research firm SFBC International We started by posting about allegations that private, for-profit clinical research firms, including SFBC International, supervised by for-profit institutional review boards (IRBs), were doing sloppy and shoddy work. We then noted allegations that SFBC International had tried to threaten or intimidate research subjects who talked to reporters about such poor research practices. Furthermore, we discussed how a review commissioned by the company found that a top executive, Jerry Seifer, SFBC International's Vice President for Legal Affairs, threatened participants in clinical studies who had talked to the press with deportation. Seifer, it turns out, had been the subject of past regulatory sanctions by federal regulators. In addition, study participants in a trial of an immunosuppressant drug carried out by the firm's Canadian subsidiary, SFBC Anapharm, acquired tuberculosis after exposure to another participant with active disease, despite their complaints to Anapharm staff. More recently, we noted that Seifer had resigned, and the company's stock price had fallen. Finally, we noted allegations that 20 people, including trial participants and staff at SFBC International's Montreal facility acquired latent tuberculosis after exposure during trials.

Per Bloomberg News, SFBC International just announced it will shut down its facility in Florida that was the location of allegedly sloppy and shoddy research practices noted above. In fact, the Miami-Dade County Unsafe Structures Board gave the company 60 days to "file a permit to demolish its Miami facility.... The company said it would appeal the ruling and may file [for] an injunction." Bloomberg quoted Kenneth Goodman, Director of the University of Miami's bioethics program, who had toured the Miami area facility,

This is going to send a signal through the entire drug industry that human-subject protection is not a nicety or a courtesy, but a bold-faced moral and legal requirement.
What I saw was a research mill where vulnerable poor and uneducated people were being enticed into taking medical risks to make a living. That's a morally flimsy foundation to advance medical knowledge.

Summary

The cases of the Ketek trial, the TGN 1412 trial, and various trials done by SFBC International have rarely been juxtaposed, except on Health Care Renewal. However, their juxtaposition suggests

Physicians and patients should be extremely skeptical of the results of drug research carried out by contract research organizations sponsored by pharmaceutical companies, since the design and implementation of such studies may not be what they seem. Other evidence that commercial research sponsors may manipulate the design of studies, the analysis of their data, and the dissemination of their results should only add to this skepticism (see most recent post here).

People should be extremely wary about signing up as subjects for such trials, since their risks may be worse than they realize

We ought to rethink the social desirability of the current relatively unregulated system of having human clinical research sponsored by commercial firms with interests in their results.

We are clearly on a "morally flimsy foundation to advance medial knowledge."

Thursday, May 18, 2006

Its been more than three weeks since we posted about the University of Medicine and Dentistry of New Jersey (UMDNJ). UMDNJ now is operating under a federal deferred prosecution agreement with the supervision of a federal monitor (see most recent posts here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See post here, with links to previous posts.)

FBI agents raided a South Jersey campus of the University of Medicine and Dentistry of New Jersey yesterday afternoon after they were tipped that documents tied to an ongoing criminal probe of a high-ranking state senator were being systematically shredded.
The agents ordered officials at UMDNJ's School of Osteopathic Medicine in Stratford to turn over those documents by today. They also subpoenaed individual school officials to appear today before a federal grand jury in Newark investigating whether any key documents were destroyed.
The records sought related to the university's dealings with state Sen. Wayne Bryant (D-Camden)....
Bryant, chairman of the Senate Budget Committee, became one focus of the investigation after the monitor questioned whether the powerful senator steered millions of dollars in state funds to the osteopathic school after he was hired there as a program support coordinator.
Sources said yesterday's dramatic events began about 2 p.m. after someone called a hotline in the office of the monitor, former federal Judge Herbert J. Stern, to report that records 'that could have significance' were being shredded in the office of Warren Wallace, the senior associate dean for academic and student affairs at the osteopathic school.
A political ally of Bryant, Wallace himself has become a subject of the ongoing investigation at the Stratford campus, but has not been accused of any wrongdoing.
The explanation from officials on the Stratford campus, located just outside Camden, was that the documents being shredded consisted of antiquated student records and faxes of records for which there were hard copies, the sources said.
However, the university had ordered months ago that no records be destroyed as the federal investigation widened.
[UMDNJ Interim President] Vladeck said he immediately ordered the shredder unplugged and taken out of use. The FBI later confiscated the machine, the sources said.

You just can't make this stuff up.

It would be almost funny, if it were not going on at an academic health care institution, in fact, the largest health care university in the US. Instead, it's tragic that the former leaders of this once proud institution let or caused it to fall so far.

We have posted frequently about the lavish compensation given to Dr William McGuire, the CEO of UnitedHealth Group, one of the largest health insurers/ managed care organizations in the US, the contrast between his compensation and the company's stated mission to provide affordable health care, questions about the timing of the granting to Dr McGuire of now $1.6 billion worth of stock options, and concerns about conflicts of interest affecting the company's governance. (See most recent post here, contains links to earlier posts.)

Now further questions have surfaced about the stock options. Various news services (e.g., TheStreet.com here) have reported that the company has been served a subpoena from a US Attorney and received a request for information from the US Internal Revenue Service (IRS) related to these stock options. On top of that, UnitedHealth was just sued by Omnicare over how United dealt with Omnicare vis a vis its Medicare prescription drug business (see Reuters).

It does make one wonder just what the priorities of UnitedHealth Group's leadership were.

We have posted frequently about governance problems at the huge University of California (UC) system, most recently here and here.

Yet more reports have appeared about the university treated top managers. According to the San Francisco Chronicle, a report just given to the system's regents showed that the university gave out 700 separation agreements worth $23 million to university employees. Several involved fairly large amounts of money. A number seem to have violated university policy that requires notification of the regents of legal agreements worth more than $250 K or involve settlements.

Also according to the Chronicle, "University auditors told the UC Board of Regents they had found that 143 exceptions to the university's compensation policies had been made to give extra pay or benefits to 113 senior managers. That's on top of the 91 exceptions identified last month by PriceWaterhouseCoopers auditors for a different group of UC executives." Furthermore, "the audit found that the university had skirted its own rules by granting extra vacation time, asking regents to approve large raises without informing them that the raises were beyond policy limits and giving large relocation incentive allowances to executives moving within California."

Some state legislators responded with anger directed at the current President of UC, Robert Dynes. Sen. Gloria Romero (D- Los Angeles) said to him, "you have had sufficient opportunity to implement accounting reforms and to get rid of compensation abuses in the university. Instead, it seems the problems have flourished under your watch. President Dynes, I look to you to exhibit leadership, I ask you to resign." Two other Senators have called for Dynes' resignation.

Dynes responded by blaming a culture of "paranoia." He further described the university's climate, "it's a climate of exceptions, and it is a climate of trying to get away with as much as possible and disclose as little as possible...."

As we have noted before, the University of California has provided an unfortunate example of a university (which includes multiple medical schools and academic medical centers) where the de facto, if not de jure rules for the executives were very different from those for the faculty, staff, and students. A leadership climate of "exceptions," and of "paranoia," may benefit the leaders, but not the organizations' other constituencies, and certainly not its mission.

Wednesday, May 17, 2006

A while back, we posted about the firing of the editors of the Canadian Medical Association Journal (CMAJ), noting this seemingly unfortunate example of a power struggle within a medical organization. However, the firing of Dr Hoey has generally been presented in terms of abuse of power as a violation of editorial independence.

For example, in 2005, Hoey wrote an unsigned editorial in CMAJ that started with the premise, "freedom from interference in editorial decisions stands at the heart of the credibility of any reputable journal." He then announced "we have a transgression to report," and then went on to recount how "a CMA [Canadian Medical Association] executive objected strenuously to a news article we were preparing on behind-the-counter access to levonorgestrel (Plan B)."(1) Similarly, the editor of the British Medical Journal responded to Hoey's firing, "this is a sorry tale that shows how little the CMA (its officers and - since there is no sign of a concerted outcry from them - its members) understands what it means to be the custodian of an international academic medical journal."(2)

There has been much more discussion of the firing of Hoey and then the departure of many other CMAJ editors. The New England Journal of Medicine ran a commentary in March.(3) Last week, it ran another, this time written by Dr Hoey, himself.(4) Would this more clearly delineate what happened?

Hoey's article, however, took an unusual stance. He chided "owners [who] may wish to limit to limit the scope of their journal, to restrict its editorial perspective to matters of bedside medicine and the narrower interests (as perceived by the usually nonphysician publishers) of their physician readership." He then denied this "vision." Instead, he proclaimed, "for Foucault, medicine is a political act."

That is where he lost me, decisively. The Foucault he cited, assuredly is Michel Foucault, one of the "postmodern vanguard," authorities repeatedly cited to justify the fashionable post-modern concepts that have swept through the academic humanities and social sciences. Foucault is cited:

For his hostility to the Enlightenment. For example, he wrote, "it is meaningless to speak in the name of -or against - Reason, Truth, or Knowledge."(5) Hicks explained, "Postmodernism rejects the entire Enlightenment project. It holds that the modernist premises of the Enlightenment were untenable from the beginning and that their cultural manifestations have now reached their nadir. While the modern world continues to speak of reason, freedom, and progress, its pathologies tell another story. The postmodern critique of these pathologies is offered as the death knell of modernism: 'The deepest strata of Western culture' have been exposed, Foucault argues, and are 'once more stirring under our feet.'"(6)

To support the self-contradictory and ultimately meaningless assertion that there is no external reality, that reality is "socially constructed." "Foucault at times suggested that underlying what counts as objective knowledge is a power relation, one category of people benefiting at the expense of another category of people. The radicals thus see the social construction of reality...."(7)

To support totalitarianism. "As part of the attack on the Enlightenment, the critique of truth suffers from a tendency to reinforce pre-enlightenment despotism. The Enlightenment replaced individual and institutional power with more objective measures of validity, and it is no surprise that the rejection of objectivity collapses back into power as a means for defining absolute truth."(8) Foucault's belief that "liberal democracies are actually more oppressive than medieval despots or even modern totalitarians,"(9) was consistent with his occasional embrace of totalitarian rulers. In 1971, he said, "when the proletariat takes power, it may be quite possible that the proletariat will exert toward the classes over which it has triumphed a violent, dictatorial, and even bloody power. I can't see what objection could possibly be made to this."(10) Similarly, he extolled the 1978 Iranian revolution, "exulting in the 'intoxication' of revolution and the violent expression of 'collective will,' and praised its leaders 'political spirituality,' which he thought reflected a health 'religion of combat and sacrifice.'"(11)

In my humble opinion, citing Foucault as an authority suggests a sympathy for post-modernism that would not be helpful to a journal editor. Most of editing is about science, and science does not fit with the notion that external reality does not exist. Readers of Health Care Renewal are certainly aware that medicine and health care are influenced by politics. But the notion that politics is all of medicine, or a totalitarian world view will not help us address concentration and abuse of power.
But perhaps Hoey's citation of Foucault was a mistake, or misinterpretation. After citing Foucault, Hoey admonished journal editors not to discuss or even divulge editorial decisions to their publishers, for that would "gut the editorial independence of a journal." However, the editor's outlook and assurance should include "an eager propensity to poke a stick into something or somebody." That proclamation suggests that Hoey's reliance on Foucault was not some mistake. Characterizing an ideal journal editor as an undisciplined trouble-maker fits Foucault's fascination with "limit experiences."(12) Yet editors whose main joy is in poking sticks into something or somebody without restraint or accountability will only add to concentration and abuse of power.
Thus, it still seems like our original characterization of the dispute at CMAJ was apt, "A classic power struggle within medicine's increasingly less-hallowed halls. Here it seems drearily familiar." That's too bad.
References
1. CMAJ. The editorial autonomy of CMAJ. Can Med Assoc J 2006; 174: 9.
2. Godlee F. A big mistake. Brit Med J 2006; 332:
3. Shuchman M, Redelmeier DA. Politics and independence - the collapse of the Canadian Medical Association Journal. N Engl J Med 2006; 354:1337-1339.
4. Hoey J. Editorial independence and the Canadian Medical Association Journal. N Engl J Med 2006; 354: 1982-3.
5. Hicks SR. Explaining Postmodernism: Skepticism and Socialism from Rousseau to Foucault. Tempe: Scholargy Publishing, 2004. P. 2. (Link here)
6. Hicks, P. 14.
7. Farber DA, Sherry S. Beyond All Reason: the Radical Assault on Truth in American Law. New York: Oxford University Press, 1977. P. 24. (Link here)
8. Farber, Sherry. P. 106.
9. Farber, Sherry, P. 29
10. Lilla M. The Reckless Mind: Intellectuals in Politics. New York: New York Review of Books, 2001. P. 150. (Link here.)
11. Lilla. P. 154.
12. Lilla. P. 150.

Monday, May 15, 2006

We have posted frequently (most recently here) about the lavish compensation given to the CEO of huge managed care organization UnitedHealth Group, how it related to the company's stated mission to provide affordable health care, and now how it inspired a not terribly succesful stock-holder revolt.

Two news articles from the mid-west contrasted how UnitedHealth is regarded by stockholders versus how it is regarded by doctors, hospitals, and regulators. In particular, the Lincoln (NE) Journal Star reported:

While UnitedHealth Group profits were soaring and its CEO was collecting more than a billion dollars in stock options, Nebraska doctors, hospitals and patients were experiencing frustrating claim payment problems, according to Department of Insurance records.
It took several years of state monitoring and prodding, a $62,500 state fine and audits, to improve the health care giant’s claims record.
Despite improvements, physicians and hospitals, frustrated by the history of problems, are still keeping a wary eye on United Healthcare Insurance Company, which had 22 percent of the Nebraska health insurance market in 2004, based on an American Medical Association study.
'We have learned not to trust —that better now does not mean better forever,' said [Chairman of the Committee on Health Insurance for the Nebraska Medical Association Dr David] Filipi.
'The problem with this company is that you fix one problem and another one crops up,' said Roger Keetle, with the Nebraska Hospital Association.'It’s just a continual floating craps game. It’s gone from horrible to better. But this is still the worst company (for payment) we have,' Keetle said.
United Healthcare spokesman Greg Thompson said the company has no comment on the Nebraska issues and [the state] audit.
The agency audit in 2004 of both the HMO (health maintenance organization) and PPO (preferred provider organization) services indicated claims that were eligible were not being paid and claims were getting lost.
[Nebraska state Director of Insurance Tim] Wagner said he was particularly frustrated and incensed because the chief executive officer was getting paid a lot of money for his performance, and what we were seeing here was that they had not done that good of a job.'
'It’s amazing that a company with these resources can’t figure out how to pay a claim,' said Keetle of the state hospital association.
'It’s a company that has been highly profitable, and there is a reason why. They do a nice job of dealing with businesses. They have a tremendous Web site. They do a tremendous job of talking about quality. But their own administrative policy is a disaster,' said Keetle.

Furthermore, the St. Paul Pioneer Press contrasted favorable reviews of UnitedHealth among stock market analysts and doctors' views of a company as "among the worse of the insurance ogres, denying payments and pressuring those on the front lines to cut back care." They quoted a pediatrician, "the shareholders have been misled and deluded. They think Bill McGuire is brilliant, but they can't tell you why." An orthopedic surgeon charged "they just do a better job of health care denial. UnitedHealth Group is making all this money at the expense of giving patients the care they need." Another doctor said the company's behavior "demonstrates the unrestrained greed and arrogance of an organization that has systematically undermined the very health care system that provides the basis for its wealth."

Maybe more managed care investors should start listening to how their companies are regarded by those who have to deal with them on the ground.

Although this may seem a bit far afield for Health Care Renewal, the recent story of Kaavya Viswanathan, the Harvard student who quickly went from acclaimed novelist to being accused of plagiarism opened a new, and troubling window on how students are admitted to college, and even medical school.

The Harvard Independent reported that Ms Viswanathan wrote in the acknowledgements page of her now withdrawn novel, How Opal Mehta Got Kissed, Got Wild, and Got a Life, how she got "a helping hand from beginning to end," from Katherine Cohen. "Cohen is the founder and CEO of IvyWise, a private college-counseling firm perhaps best known for charging prices that would be exorbitant for all but a tiny sliver of Ivy-ambitioned parents."

Such services, and IvyWise in particular, were discussed as early as 2001 in New York Magazine . This article described "a prosperous new breed of private counselors who are helping the children of the rich attain their birthright of getting accepted to the Ivy League college of their choice despite the ever-mounting odds against them." Furthermore, "In order to enhance their chances of achieving glory (it goes without saying that their kids' SATs and GPAs are already in the steroid-enhanced range), families are chasing their dream by employing that most American of strategies for success -- marketing. 'I hear families use the word packaging,' says the mother of a senior at one of the city's most competitive girls' schools. ''We're packaging our daughter. The hair stands up on the back of your neck. They made an investment, and they want a return.'" These packaging services are capable of nearly taking over high-school students' lives for as long as their high-school career. The cost of the IvyWise platinum package (in 2001) was close to $30,000.

The Harvard Independent described the intensive involvement of such packaging services in students' lives. IvyWise's Cohen said, "I really look at everything going on in a student's life and plan everything from courses for four years to summers to outside activities and focus on strengthening whatever weaknesses (academic and personal) may come up." Furthermore, per the New York Magazine article, "The guidance counselor isn't above hitting up friends in high places for internships when a teenager's brag sheet could use a little fluffing." A follow-up article in the Harvard Independent declared, "perhaps the most striking aspect found in the wealth of coverage linked to on IvyWise.com is the intense level of control that the company's counselors had over clients' academic and social lives. Indeed, if Cohen did in fact limit herself to projecting already-present qualities in her clients, many of them must have walked into IvyWise's Manhattan offices with little or no sense of who they truly were." The article includes copious quotes from the Ivywise web-site that show how Ivywise may affect aspects of students lives from their weekend schedule to whether they attend summer camp, thus, "true selves do not go into sessions with Cohen so much as emerge from them."

Local Rhode Island columnist Mark Patinkin summarized it nicely, "If your kids are applying to Ivy League schools but don't have such an agency behind them, the Kaavya's of the world have the advantage." "So Kaavya wasn't just another 'student' applying to Harvard. She was an elaborately packaged 'pitch.'" He concluded, "once, standout kids in America achieved success through hard work. Today, instead, they are carefully packaged for success by adults."

But there’s something fundamentally untoward about the cynical lessons that such a makeover process teaches the kids who go through it—especially when it seems to work.
We’ve forged a society in which misrepresentation is routine, encouraged, obligatory. For all her sweet Hogwarts dreams, an observant, canny, IvyWised-up kid is bound to draw certain conclusions about the way the real world works.
[the student] had already come to understand that her success so far was not just a matter of talent and discipline but of buying the right connections, cutting deals for behind-the-scenes assistance, cunning.

So how is this relevant to Health Care Renewal? As noted above, the IvyWise packaging process does seem to teach the cynical acceptance of misrepresentation, a notion that may be at the root of many of the stories on Health Care Renewal. Presumably, this lesson may be transmitted informally not just to students "packaged" by one service or another, but to others exposed to them.

More directly, some of the Ivywise packaged students may have already gone on to careers in medicine or health care. Finally, Ivywise offers to "counsel" students who apply to medical school. How often medical students have been packaged by one "counseling" service or the other, and the effects thereof, have yet to be investigated.

Friday, May 12, 2006

We have previously discussed, most recently here and here, the tremendous largesse afforded Dr William McGuire, the CEO of UnitedHealth Group by his board of directors. Although UnitedHealth's mission statement includes improving access and making health care more affordable, Dr McGuire now owns approximately $1.6 billion worth of unexercised stock options. We also discussed (here and here) the potentially major conflicts of interest affecting several UnitedHealth board members who are also leaders of not-for-profit academic and research health care or organizations.

Now various news services (for example, the Associated Press) have reported the UnitedHealth had admitted a "significant deficiency" in its handling of stock options, and warned that it may have to restate its earnings over several years, it is the subject of an "informal inquiry" by the US Securities and Exchange Commission (SEC), it may have an added tax liability for some of the stock options given to managers, seven lawsuits have been filed by shareholders, and that an unidentified shareholder demanded that the board "take action to remedy breaches of fiduciary duties and unjust enrichment by the directors and certain officers in connection with the company's stock option granting practices."

We have discussed how early advocates of managed care called for "breaking up the [physicians] guild" and handing the power to run health care over to managers and bureaucrats, like those who run UnitedHealth. Now people in the investment world may be starting to understand what managers and bureaucrats have done with with this power. We physicians on the ground in the health care world have been seeing these effects for a while.

Thursday, May 11, 2006

The Cleveland Clinic has announced major changes in how it handles conflicts of interest. Last year, there was considerable media coverage of alleged conflicts affecting a variety of Clinic leaders (see most recent post here.)

Previously, the Clinic had announced that it will host a symposium on conflict of interest, which "hopes to attract more than 500 leaders in research, medicine, industry, government and bioethics." (See the Cleveland Plain Dealer.)

The Associated Press reported (via the Washington Post) that the Clinic's board of trustees will create a standing committee on conflicts of interest, which will meet regularly with staff. They will also create a data-base covering all people who work for the clinic. They will "require disclosure and competitive bidding if the business of an outside trustee is trying to sell to the clinic." The New York Times added that the "clinic will prevent doctors who have relationships to particular drug or device companies from involvement in the clinic's purchasing decisions about these companies' products."

However, the Times also noted that "the clinic has stopped short of making information about the outside relationships of its doctors and trustees available to patients and others outside of the clinic itself."

An article in the Cleveland Plain Dealer added some further skepticism, noting that the board was "short on specifics," and noting that David Rothman of the Institute of Medicine as a Profession "wondered how the board's commitment would translate into practice and whether the hospital would, for example, make its database available to patients who want to know if their physicians have stock in certain companies."

I guess these are some signs of progress, although it is disconcerting that the Clinic will not make their conflict of interst database public, nor ban dealing with organizations in which members of the board of directors have a direct financial interest.

Almost all the advertising in multispecialty journals is from pharmaceutical (and sometimes device)companies - Some journals have policies that restrict advertising only to products related to medical practice. A study of one-sixth the issues of a prominent journal for the last 10 years showed that drug advertising made up from 95% to 99% of the advertising content per year.

Advertising rates in medical journals are actually generally lower than rates for relatively upscale consumer magazines with similar circulations - For example, the authors compared cost per thousand readers exposed for one-time full-page four color advertisements, which ranged from US $43 to $88 for four major American journals, but from $86 to $110 for five US consumer magazines. "Some medical journals trumpet their bargain rates." One advertised in Medical Marketing and Media as providing "a priceless audience. At a price you can afford."

Medical journals enable marketers to target specific physician sub-groups, by region, by specialty, or even by prescribing patterns - One prominent journal advertised to marketers, "you can run your Cancer of HIV/AIDS related product to a special list of high-prescribing physicians, including key oncology and infectious disease doctors."

Physician organizations may receive substantial portions of their revenue from the mainly pharmaceutical and device advertising in their medical journals - One large organization gets 15.1% of its total revenue from such advertising.

So, the authors asserted, "by accepting only advertisements for drugs and medical devices, medical journals have accepted an exclusive and dependent relationship with corporations." The authors asserted that this relationship has lead to effects on editorial decisions and content. They quoted the former editors of a prominent journal, "the pharmaceutical industry showed us that the advertising dollar could be a two-edge sword, a carrot or a stick. If you ever wondered whether they play hardball, this was a pretty good demonstration that they do."

The authors' recommendations centered on the curious fact (which we readers of general medical journals have noticed but ignored for a long time) that

Although physicians would be expected to be a desirable audience for purveyors of cars, golf clubs, cruises, and luxury goods, advertisements for consumer goods in medical journals are conspicuous by their absence. Orentlicher and Hehir have argued compellingly that if advertisements for luxury goods were accepted, 'journals would have a larger pool of companies to which they could sell advertising space, and they would reduce the conflict of interest that arises from the practice of only accepting health care advertisements. This suggests that health care companies are not the first place medical journals should look for advertising. Rather, they are the last place medical journals should look .'

So,

Accepting advertising for consumer goods removes the conflict of interest inherent in pharmaceutical advertising, but more importantly may free editors from the threat of lost revenue. It is disturbing that medical journals appear to have exclusive, largely undeclared arrangements with pharmaceutical companies. It could even be argued that it is poor business practice to forego more lucrative advertisements in order to provide cut-rate advertising to manufacturers of drugs and devices. If purveyors of consumer goods are willing to advertise in medical journals, replacing drug advertisements with advertisements for consumer goods could bolster both the bottom line and editorial freedom.

Although, of course,

Another option is to eschew journal advertising altogether.

My college alumni magazine, which presumably goes to a fairly affluent audience, containts tasteful advertisements for cars (from Mercedes-Benz to Bentley), real estate, travel and vacation destinations, financial services, electronics and optics, and books and recordings. The medical journals sitting in a pile in my office contain not a single such advertisement, even though physicians might provide a good market for such products. These patterns have been in place for years. I have seen them for years.

Sometimes the most important facts and ideas are just sitting in front of our faces, waiting for us to see them.

We have previously posted, most recently here, about the disastrous trial, implemented by Parexel International , of a new monoclonal antibody designated TGN 1412, manufactured by TeGenero AG. All six healthy volunteers who got the antibody soon became critically ill.

Unlike some other cases discussed on Health Care Renewal, this one had already received attention in prominent UK medical and scientific journals, including the British Medical Journal, the Lancet, and Nature. It's good to see that the most prominent US medical journal has weighed in.

The article by Wood and Derbyshire focused on the following points, in the article's own words (with emphasis added):

At some point in the development of every drug, the drug must be given for the first time to humans in a phase 1 trial. Until now, such trials have had a remarkably good safety record....
It is standard practice to begin with very small doses, often orders of magnitude below those determined to be nontoxic in animals and those expected to produce any effect in humans. Doses are then increased slowly, as the experience at lower doses is continually evaluated.
System or human failures — such as errors in dosage, manufacturing, or administration — are usually prevented by rigorous procedures for drug preparation and administration.
Toxic effects such as acute liver injury, leukopenia, cardiac arrhythmia, or rash may be related to the new drug molecule itself but unrelated to its intended mechanism of action. Considerable efforts are made to identify these types of toxicity in vitro and through studies in animals. However, our incomplete understanding of the mechanisms underlying such toxicity and the limitations of animal models inevitably mean that some potentially serious toxic effects go undetected in preclinical screening....The second type of toxic effect results from the action of the drug on its intended biologic target. Such effects are always unknown when a target is 'drugged' for the first time — and there must always be a first time.When a compound addressing a new biologic target is tested for the first time in humans, much greater caution must be exercised. Such caution should include avoidance of treating multiple volunteers simultaneously or without a reasonably long interval between them.
In some cases, a phase 1 trial does not, in fact, represent the first attempt to manipulate a particular biologic target — though the researchers may be unaware of previous efforts. Clearly, we should not be exposing people to such manipulation if it has been shown, in studies in either humans or animals, to carry serious risks outweighing any potential benefits.Unfortunately, the companies that generate early safety data consider them proprietary — a concern that must somehow be reconciled with patients' safety. Volunteers rightly expect that we put their safety before competitive advantage, and researchers have an ethical obligation to prevent the exposure of additional volunteers to previously identified risks.
How can we improve the knowledge base for designing trials of new drugs directed at novel targets and make it available to developers and regulators when they are considering the safety of such trials? One approach would be to ensure that all data from preclinical drug research are held in a secure database, indexed by biologic target, and accessible only by major regulatory authorities, which are used to handling confidential data.
There are fundamental questions about which, if any, details of a clinical trial involving volunteers should ever be confidential or whether safety and ethics principles can be ensured only by an open, transparent process in which such trials and protocols are registered in a public database.

The commentary presented a reasonble summary, but it seemed to tread lightly in certain areas.

In particular, it side-stepped the question of whether that there was particular information available before the TGN 1412 trial that would have suggested that affecting the CD28 receptor targeted by TGN 1412 might be dangerous. There is at least a question about this. An article in the (UK) Times quoted Angus Dalgleish, "the previous studies which caused similar side effects were in patients already suffering from cancer, but [the researchers] should have known they would get a meltdown because the drug was hitting exactly the same target." An article in Nature (Hopkin M. Can super-antibody drugs be tamed?) stated, "with hindsight, it might be no surprise that the compound, dubbed a 'superagonist' antibody by its creators, could run amok in the immune system." Furthermore, research on drugs that target the CD3 receptors in mice, which have a similar function to the CD28 receptors, showed, "uncontrolled cytokine release was a problem - albeit not a large one because the mice were already immunodepleted...."

Finally, it did not challenge the notion that safety data about particular drugs should be kept confidential during drug development. In constrast, Goodyear (see above), wrote, "this tragedy creates one more imperative for an open culture in medical research, a culture that many fear is increasingly losing its way."

Given that Dr Wood, the first author of this article, already consults for and will soon become a top leader in an organization that buys rights for particular drugs from biotechnology companies and then helps to run clinical trials on them, his choice of emphasis is understandable. Perhaps someone from a different background would have placed emphasis elsewhere.

But it is time for the final twist. The New England Journal only identified Dr Wood as "a professor of medicine and pharmacology at Vanderbilt University School of Medicine." It did not mention Dr Wood's current or future positions with Symphony Capital. Yet Dr Wood's new position at Symphony Capital had been made public by the New York Times two days before the article was published.

It seems that prominent medical journals still have difficulties disclosing financial and other interests of authors that might meaningfully affect their opinions, and might be relevant to readers who want to understand where these authors are coming from.

We have posted quite a lot about Guidant, most recently here. As per a previous New York Times article, "the Guidant Corporation came under scrutiny last spring for not telling doctors about potentially fatal defects in its heart devices."

ECRI Inc is a Philadelphia area not-for-profit organization that publishes a "PriceGuide" which lists the average and lowest regional prices paid by hospitals for medical devices. According to the Inquirer, "Guidant wants to stop ECRI Inc., a Plymouth Meeting nonprofit group that examines the safety, efficacy and cost of medical equipment, from publishing actual prices paid by hospitals for the company's devices." In response, "ECRI filed suit in federal court here last week seeking permission to 'continue to publish truthful information that hospitals voluntarily provide to it concerning the prices that they pay for medical devices."

Starting two years ago, Guidant lawyers began objecting to the inclusion of its products in the database, saying that 'price information was subject to confidentiality agreements between Guidant and its customers,' according to ECRI's federal complaint.
Guidant has argued that confidentiality clauses in its contracts with hospitals prevent sharing of actual cost information with third parties, such as ECRI or group purchasing organizations.
A Guidant spokesman referred questions about the matter yesterday to Boston Scientific Corp., which completed its $27 billion acquisition of the company last month.
Paul Donovan, a spokesman for Boston Scientific, said pricing confidentiality has long been the standard practice in the heart-device industry and serves customers and manufacturers well.
'It's a fairness issue,' Donovan said. 'We simply don't want the price negotiated privately with one hospital based on one set of circumstances used against us in negotiations with another hospital.' In February, a federal judge in Minnesota ruled that a health-care consulting firm was not allowed to share Guidant prices it obtained from one hospital client with other institutions.

The Inquirer reported support for ECRI's arguments,

The suit 'is about the public interest in making health care affordable and available,' said Joyce S. Meyers, a lawyer at Montgomery, McCracken, Walker & Rhoads L.L.P. in Philadelphia, representing ECRI.
The more information available on the quality and price of equipment and devices, the better for patients, said John J. Kelly, chief medical officer of Abington Memorial Hospital.
In a financially difficult environment for hospitals, ECRI serves as 'the Consumer Reports of health care,' he said.
If Guidant prevails, other medical-product manufacturers are likely to follow, said Michael J. McShane, a spokesman for the Health Industry Group Purchasing Organization, which represents companies that buy goods for large groups of hospitals.
'Ultimately, the cost will be passed on to the insurance companies and Medicare, and then right back to the consumers in higher premium rates and higher taxes,' McShane said.
Paul Alan Levy, a lawyer with the consumer advocacy group Public Citizen, which is also representing ECRI in the suit, said price, safety and effectiveness are necessary elements for hospitals to know when buying a product.
He said: If Guidant gets away with this, maybe others will try to do the same thing, and the marketplace would be the poorer for it.'

In my humble opinion, the arguments made on behalf of ECRI's stance are good ones. If we are going to rely on the market to reduce health care costs, that market must have available clear information about the price of health care goods and services. Furthermore, as Transparency International's 2006 report on corruption in health care, uncertainty and assymetrical information make corrupt practices easier.
Finally, in health care, where decisions affect peoples' health and safety, patients and physicians ought to seek to use products and services for which there is good evidence suggesting that benefits outweigh the risks. Patients and physicians may justifiably hesitate to use products and services from organizations with reputations for obscuring data about their products and services. Thus, I urge the leaders of Guidant (now Boston Scientific) to embrace transparency as a good business practice likely to improve their fortunes in the long run.

Pfizer selected the patients at a field hospital in the city of Kano, where the children had been taken to be treated for an often deadly strain of meningitis.
Pfizer contended that its researchers traveled to Kano with a purely philanthropic motive, to help fight the epidemic, which ultimately killed more than 15,000 Africans.
Pfizer had told authorities that a Nigerian doctor directed the experiment. The committee, however, found that researchers from Pfizer's U.S. office controlled the trial, and the inexperienced Kano doctor, Abdulhamid Isa Dutse, was the principal investigator 'only by name.'
The panel said an oral form of Trovan, the Pfizer drug used in the test, had apparently never been given to children with meningitis. There are no records documenting that Pfizer told the children or their parents that they were part of an experiment, it said.
Dutse admitted that he created a letter after the experiment purporting to show that the test had been approved in advance by a Nigerian hospital's ethics committee. He then backdated the letter to March 28, 1996 -- a week before Pfizer's experiment began.
Pfizer used the letter as a key justification for the trial in discussions with reporters and submitted it to the FDA.
The Post previously reported that the hospital had no ethics committee in March 1996 and that the letterhead stationery used was not created until months after the experiment's conclusion.
The former director of Nigeria's version of the FDA said the agency had been unaware of the experiment. He told the panel that he viewed the conduct of the trial by Pfizer as an act of deception and misuse of privilege.'
The report said the treatment of two children during the experiment represented unspecified 'serious deviations' from the trial's protocol and concluded that those deviations compromised their care.
Pfizer's experiment was 'an illegal trial of an unregistered drug,' the Nigerian panel concluded, and a clear case of exploitation of the ignorant.'

Pfizer's response was,

Pfizer contended that its researchers traveled to Kano with a purely philanthropic motive, to help fight the epidemic, which ultimately killed more than 15,000 Africans. The committee rejected that explanation, pointing out that Pfizer physicians completed their trial and left while 'the epidemic was still raging.'
Executives at Pfizer, the world's biggest drug company, said they had not seen the report. After reviewing a copy, they responded in a two-page statement:
'The Nigerian government has neither contacted Pfizer about any of the committee's findings nor are we aware that the committee has approved a final report. Therefore it would be inappropriate for the company to respond to specific points in the document.'
'However, as we have stated repeatedly over the past several years, Pfizer conducted this trial with the full knowledge of the Nigerian government and in a responsible way consistent with Nigerian law and Pfizer's abiding commitment to patient safety.'

Why it took so long for this report to be made public is unclear.

The Washington Post recently obtained a copy of the confidential report, which is attracting congressional interest. It was provided by a source who asked to remain anonymous because of personal safety concerns.
Aspects of the affair remain mysterious, such as why the report remains confidential. The head of the investigative panel, Abdulsalami Nasidi, said in a brief telephone conversation from Nigeria, 'I don't really know myself' why the report was never released.
Dora Akunyili, director of the Nigerian drug control agency, said she did not know why the report remained confidential but added that her agency had independently concluded that 'these people did not have authority to conduct the trial.'

It sounds like Pfizer CEO Hank McKinnell (see related post here) has another big issue to deal with, albeit retrospectively. This story sounds another warning that physicians and patients need to be skeptical about how clinical research sponsored by commercial firms was actually implemented.
The Post further reported,

Last week, Rep. Tom Lantos of California, the senior Democrat on the International Relations Committee, described the report's findings as absolutely appalling' and called on Pfizer to open its records.
Lantos said he expected to introduce a bill requiring U.S. researchers to give regulators details of tests they plan in developing countries.

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